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Glossary

EUDAMED

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The European database for medical devices EUDAMED is to centralize: 

  • Data relating to registration of manufacturers and medical devices placed on the community market, 
  • Data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused, 
  • Data obtained in accordance with the vigilance procedure, 
  • Data concerning clinical investigations. 

Other glossary definitions

P

Patient Information Leaflet (PIL)

Patients invited to participate in a clinical trial (=subjects), and/or in specific circumstances their legally…

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S

Safety concern

An important identified risk, an important potential risk, or important missing information.

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